(121 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This is a medical device, but it is not an AI/ML powered device, nor is it a device that requires image analysis or complex diagnostic algorithms. Therefore, many of the requested criteria such as "test set", "training set", "experts", "ground truth", "adjudication method", and "MRMC comparative effectiveness study" are not applicable to this type of regulatory submission. The submission is for a physical product, a glove, and its performance is assessed against physical and chemical standards.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets ( |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.